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Chapter IV — Conformity assessment

Article 25 — Conformity assessment procedures for machinery and related products

  1. The manufacturer or the natural or legal person referred to in Article 18 shall apply one of the conformity assessment procedures referred to in paragraphs 2, 3 and 4.

  2. Where the category of machinery or related product is listed in Annex I, Part A, the manufacturer or the natural or legal person referred to in Article 18 shall apply one of the following procedures:

    (a) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;

    (b) conformity based on full quality assurance (module H) set out in Annex IX;

    (c) conformity based on unit verification (module G) set out in Annex X.

  3. Where the category of machinery or related product is listed in Annex I, Part B, the manufacturer or the natural or legal person referred to in Article 18 shall apply one of the following procedures:

    (a) internal production control (module A) set out in Annex VI;

    (b) EU type-examination (module B) set out in Annex VII, followed by conformity to type based on internal production control (module C) set out in Annex VIII;

    (c) conformity based on full quality assurance (module H) set out in Annex IX;

    (d) conformity based on unit verification (module G) set out in Annex X.

    If a manufacturer applies the internal production control procedure referred to in point (a), it shall design and construct the machinery or related product in accordance with the harmonised standards or common specifications specific to that category of machinery or related product covering all the relevant essential health and safety requirements.

    Where the category of machinery or related product is listed in Annex I, Part B, and the machinery or related product was not designed and constructed in accordance with the harmonised standards or common specifications specific to that category of machinery or related product covering all the relevant essential health and safety requirements for that category of machinery or related product, the manufacturer, including a natural or legal person referred to in Article 18, shall apply one of the procedures referred to in points (b), (c) or (d) of this paragraph.

  4. Where the category of machinery or related product is not listed in Annex I, the manufacturer, including a natural or legal person referred to in Article 18, shall apply the internal production control procedure (module A) set out in Annex VI.

  5. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment.